Instrument for compression and distraction

ABSTRACT

A spinal stabilization system, method, and a surgical kit having a surgical extender apparatus for implanting a surgical screw are disclosed. The extender includes a housing having a distal end and a proximal end, a hollow interior passageway disposed between the distal end and the proximal end, a channel disposed along an exterior surface of the housing at least partially between the distal end and the proximal end and configured to at least partially expose the hollow interior passageway, an interior locking mechanism disposed on an interior surface of the housing and substantially adjacent the proximal end, wherein the interior locking mechanism is configured to allow attachment of at least one surgical tool, and at least one flexible member disposed substantially adjacent the distal end. The housing is configured to accommodate placement of a surgical screw implant. The surgical screw implant is secured to the housing a mating feature in the surgical screw implant. The at least one flexible member is configured to retain the surgical screw implant. The mating feature is configured to control axial movement of the surgical screw implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional PatentApplication No. 61/000,263 to Hutton et al., filed Oct. 23, 2007, andentitled “Percutaneous Wire System”. The present application also claimspriority to U.S. Provisional Patent Application No. 61/132,974 to Huttonet al., filed Jun. 23, 2008, and entitled “Method And Device ForPercutaneous Spinal Fixation”. The present application incorporatesdisclosures of these applications herein by reference in theirentireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to the field of spinal surgery.In particular, the present invention relates to the field of surgicalaccess to the spine.

2. Background

Spinal fusion is a procedure that promotes fusing or growing together oftwo or more vertebrae in the spine. Spinal fusion can be performed to

-   -   straighten a spine deformed by scoliosis, neuromuscular disease,        cerebral palsy, or other disorder;    -   prevent further deformation;    -   support a spine weakened by infection or tumor;    -   reduce or prevent pain from pinched or injured nerves;    -   compensate for injured vertebrae or disks.

One of the goals of spinal fusion procedure is to unite two or morevertebrae to prevent them from moving independently of each other. Thismay be done to improve posture, increase ability to ventilate the lungs,prevent pain, or treat spinal instability and reduce the risk of nervedamage. According to the American Academy of Orthopedic Surgeons,approximately a quarter-million spinal fusions are performed each year,half on the upper and half on the lower spine.

The spine is a series of individual bones called vertebrae, separated bycartilaginous disks. The spine includes seven cervical (neck) vertebrae,12 thoracic (chest) vertebrae, five lumbar (lower back) vertebrae, andthe fused vertebrae in the sacrum and coccyx that help to form the hipregion. While the shapes of individual vertebrae differ among theseregions, each is essentially a short hollow tube containing the bundleof nerves known as the spinal cord. Individual nerves, such as thosecarrying messages to the arms or legs, enter and exit the spinal cordthrough gaps between vertebrae. The spinal disks act as shock absorbers,cushioning the spine, and preventing individual bones from contactingeach other. Disks also help to hold the vertebrae together. The weightof the upper body is transferred through the spine to the hips and thelegs. The spine is held upright through the work of the back muscles,which are attached to the vertebrae. While the normal spine has noside-to-side curve, it does have a series of front-to-back curves,giving it a gentle “S” shape. The spine curves in at the lumbar region,back out at the thoracic region, and back in at the cervical region.

One of the types of spinal fusion procedures is a posterior spinalfusion surgery. This procedure is performed posteriorly, or from theback of patient, as opposed to anteriorly, or through the abdomen. Thereare three know posterior fusion techniques (all three are typicallyperformed with pedicle screw fixation). The first is a posterolateralgutter fusion surgery. This type of spinal fusion involves placing bonegraft in the posterolateral portion of the spine (a region just outsidethe back of the spine). The second is a posterior lumbar interbodyfusion (“PLIF”) surgery. A PLIF involves placing bone graft and/orspinal implant (e.g., cage) directly into the disc space in the front ofthe spine. The third is a transforaminal lumbar interbody fusion(“TLIF”) surgery. A TLIF is essentially like an extended PLIF, as italso involves expanding the disc space by removing one entire facetjoint (whereas a PLIF usually involves gaining access to the disc spaceby removing a portion of the facet joints on each side of the spine).

There have been various approaches and systems for performing posteriorspinal surgery. Some conventional systems further include titaniumconstruction that is compatible with current CT and MRI scanningtechnology, low profile implant systems, top-loading and top-tighteningsystems, and other parameters. Some systems also includecross-connectors that allow one-piece implant to be applied to adual-rod construct for a top-loading approach.

The conventional devices and systems have a number of disadvantages.These devices do not provide flexibility when adjusting the deviceseither prior to, during, or after their placement into the patient.Thus, these devices force a surgeon to utilize a specific configuration,leaving very little room for adjustment in accordance with patient'sphysiological characteristics and needs.

In some embodiments, the present invention relates to a minimallyinvasive bone screw placement system that allows a surgeon to implantone or more bone screws into the spine and connect the screws with awire or a any other device, wherein the system does not require anyincisions in excess of the bone screw incisions.

SUMMARY OF THE INVENTION

In some embodiments, the present invention is directed to a spinalstabilization system for stabilizing a spine using at least one asurgical screw implant configured to be implanted into the spine. Thesystem includes a housing configured to accommodate placement of thesurgical screw implant, the surgical screw implant is secured to thehousing a first mating feature in the surgical screw implant, a lockingfeature contained within the housing and configured to retain thesurgical screw implant for implantation. The a first mating feature isconfigured to control axial movement of the surgical screw implant.

In some embodiments, the present invention relates to a method ofstabilizing spine of a patient including implanting a surgical screwimplant having a housing configured to accommodate placement of asurgical screw implant, the surgical screw implant is secured to thehousing a first mating feature in the surgical screw implant, a lockingfeature contained within the housing and configured to retain thesurgical screw implant for implantation, wherein the first matingfeature is configured to control axial movement of the surgical screwimplant. The method includes implanting the surgical screw implantcoupled to the housing into a bone, manipulating the surgical screwimplant and the housing to orient the housing in a predetermined manner,advancing a wire through the housing, and using the wire, connecting thesurgical screw implant with another surgical screw implant.

In some embodiments, the present invention relates to a surgicalstabilization system using at least one screw implanted into a bone of apatient, wherein the screw includes a head, wherein the head isconfigured to include a second mating feature that can be configured toinclude a plurality of openings and a plurality of recessed edges. Thesystem includes a hollow housing having a wall surrounding an interiorof the hollow housing, an open proximal end, and an open distal end,wherein the wall is disposed between the proximal end and the distalend. The distal end is secured to the surgical screw and the surgicalscrew is delivered via the proximal end. The housing includes a flexibleportion having a first mating feature disposed along the wall of thehousing and adjacent the distal end. The flexible indenting portion isconfigured to retain the surgical screw within the housing.

In some embodiments, the present invention relates to a surgicalextender apparatus for implanting a surgical screw. The apparatusincludes a housing having a distal end and a proximal end, a hollowinterior passageway disposed between the distal end and the proximalend, a channel disposed along an exterior surface of the housing atleast partially between the distal end and the proximal end andconfigured to at least partially expose the hollow interior passageway,an interior locking mechanism disposed on an interior surface of thehousing and substantially adjacent the proximal end, wherein theinterior locking mechanism is configured to allow attachment of at leastone surgical tool, and at least one flexible member disposedsubstantially adjacent the distal end. The housing is configured toaccommodate placement of a surgical screw implant. The surgical screwimplant is secured to the housing a mating feature in the surgical screwimplant. The at least one flexible member is configured to retain thesurgical screw implant. The mating feature is configured to controlaxial movement of the surgical screw implant.

In some embodiments, the present invention relates to a method ofimplanting a surgical screw implant into a bone of a patient using a anextender device having a housing configured to accommodate placement ofa surgical screw implant, the surgical screw implant being secured tothe housing mating feature in the surgical screw implant, wherein thehousing includes a flexible member contained within the housing andconfigured to retain the surgical screw implant. The method includesimplanting the surgical screw implant into a bone of the patient,attaching the screw extender device to the surgical screw and, insertinga screw locking device along the long axis of the screw extender.

In some embodiments, the present invention relates to a surgical kit forstabilizing the spine of a patient. The kit includes a screw extenderconfigured to be coupled to a surgical screw, wherein the screw extenderincludes a housing having a distal end and a proximal end, a hollowinterior passageway disposed between the distal end and the proximalend, a channel disposed along an exterior surface of the housing atleast partially between the distal end and the proximal end andconfigured to at least partially expose the hollow interior passageway,an interior locking mechanism disposed on an interior surface of thehousing and substantially adjacent the proximal end, wherein theinterior locking mechanism is configured to allow attachment of at leastone surgical tool, and at least one flexible member disposedsubstantially adjacent the distal end. The housing is configured toaccommodate placement of a surgical screw implant. The surgical screwimplant is secured to the housing a mating feature in the surgical screwimplant. The flexible members are configured to retain the surgicalscrew implant. The mating feature is configured to control axialmovement of the surgical screw implant.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described with reference to the accompanyingdrawings. In the drawings, like reference numbers indicate identical orfunctionally similar elements.

FIGS. 1 a-c illustrate an exemplary screw extender system, according tosome embodiments of the present invention.

FIGS. 2 a-b illustrate another exemplary screw extender system,according to some embodiments of the present invention.

FIGS. 3 a-d illustrate yet another exemplary screw extender system,according to some embodiments of the present invention.

FIGS. 4 a-b illustrate an exemplary screw for use with a screw extendersystem, according to some embodiments of the present invention.

FIG. 5 illustrates exemplary coupling of the screw and the screwextender system, according to some embodiments of the present invention.

FIG. 6 illustrates a distal portion of the screw extender housing,according to some embodiments of the present invention.

FIGS. 7 a-h are bottom views of the screw extender housing having anexemplary screw remover device configured to remove the housing from theimplanted screw, according to some embodiments of the present invention.

FIGS. 8 a-d illustrate various exemplary screw extender remover tools,according to some embodiments of the present invention.

FIGS. 9 a-h illustrate an exemplary percutaneous wire inserters for usewith screw extender system, according to some embodiments of the presentinvention.

FIGS. 10 a-h illustrate an exemplary step-by-step procedure forpercutaneously inserting a wire using a screw extender system, accordingto some embodiments of the present invention.

FIGS. 11 a-b illustrate an exemplary wire advancement mechanism,according to some embodiments of the present invention.

FIG. 12 illustrates an exemplary wire, according to some embodiments ofthe present invention.

FIGS. 13 a-f illustrate an exemplary compressor/distractor tool,according to some embodiments of the present invention.

FIGS. 14 a-e illustrate another exemplary compressor/distractor tool,according to some embodiments of the present invention.

FIG. 15 illustrates an exemplary anti-splay device, according to someembodiments of the present invention.

FIGS. 16 a-c illustrate an exemplary caliper tool, according to someembodiments of the present invention.

FIGS. 17 a-c illustrate an exemplary screw extender guide tool,according to some embodiments of the present invention.

FIGS. 18 a-c illustrate an exemplary supplemental screw extender removertool, according to some embodiments of the present invention.

FIGS. 19 a-f illustrate various exemplary rod inserter tools, accordingto some embodiments of the present invention.

FIGS. 20 a-o illustrate exemplary step-by-step procedures for insertionof a rod using rod inserter tools, according to some embodiments of thepresent invention.

FIGS. 21 a-e illustrate an exemplary rod reducer tool, according to someembodiments of the present invention.

FIGS. 22 a-b illustrate an exemplary rod inserter tool, according tosome embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In some embodiments, the present invention allows a surgeon usingconventional stab wounds to place bone screws. This is typicallyaccomplished using a Jamshiti needle followed by progressive dilation.Once the bone has been prepared, the bone screw is implanted.

After implantation, the bone screw is manipulated for orientation by theextender. This “extender” extends out of the stab wound and allows thesurgeon to control the implanted screw. Once two or more screws areimplanted, the surgeon will place the wire inserters onto the screwextender. The wire components are designed to guide a wire down the axisof the screw extender. Once the desired depth is reached, the wire willexit out of the screw extender and puncture the muscle and create a pathto join the adjacent bone screw.

Once the wire bridges the gap between the screws, an instrument that hasbeen previously placed down the adjacent extender grabs the wire andpulls the distal portion of the wire to the surface. Attached to theproximal portion of the wire is a rod. By pulling on the distal portionof the wire, the rod is drawn down the extender and pulled across thegap between the screws. The “button” feature on the proximal portion ofthe rod prevents the rod from being overly pulled past the extender. Insome embodiments, the extenders along with screws and the wire insertersare disposed at the surgical site prior to advancement of the wire.

Set screws can be placed, final tightened and the guide wire can beremoved. This provides a minimally invasive placement of fusionhardware.

FIGS. 1 a-c illustrate an exemplary embodiment of a screw extenderdevice 100, according to some embodiments of the present invention. FIG.1 a illustrates the screw extender device 100 being coupled to a screw.FIG. 1 b illustrate the screw extender device 100 by itself and FIG. 1 cillustrates a cross-sectional cut out of the screw extender device shownin FIG. 1 b. Screw extender device 100 includes a housing 110 that iscoupled to a screw implant 120 using first mating features (or as shownin FIGS. 1 a-c, the indented features) 105 disposed on the head of thescrew 122. The indented features 105 are configured to control axial andtorsional movement. The housing 110 has a proximal end 102 and a distalend 104. The housing 110 further includes a partially open channel 112,which permits insertion and passage of a rod toward from the proximalend 102 toward the distal end 104 of the housing 110. In someembodiments, as will be discussed below, the housing 110 can beconfigured to include a partially open channel 112 and/or a fully openchannel, whereby the fully open channel is configured to stretch fromthe proximal end 102 to the distal end 104. The open channel isconfigured as a hollow interior or passageway 119 of the housing 110.The hollow interior 119 is configured to allow passage of instruments,rods, implants, etc. through the screw extender device during surgery.To allow such passage, the housing 110 includes an opening 108 disposedat the proximal end 102 and a similar opening disposed at the distal end104. The sizes of the openings can be substantially similar to the sizeof the interior 119. The openings allow passages of instruments, tools,rods, implants, etc. during surgical procedures. In some embodiments,the screw extender housing 110 is configured to have a cylindricalshape. As can be understood by one skilled in the art, other shapes ofthe housing 110 are possible.

The distal end 104 of the housing 110 is configured to be coupled to thehead of the screw 122. The distal end 104 includes second matingfeatures (as shown in FIGS. 1 a-c, protrusions) 115 (as shown in FIGS. 1b-c) that are configured to mate with the first (or indented) features(or openings) 105 disposed on the head of the screw 122. In thefollowing description of FIGS. 1 a-22 b, the terms “protrusion(s)”,“indentation(s)”, “first mating feature(s)”, “second mating feature(s)”will be used interchangeably, and thus, in some embodiments, the presentinvention can include a first mating feature that is a protrusion and asecond mating feature that is an indentation configured to mate with theprotrusions, whereas in some embodiments, a first mating feature can bean indentation and a second mating feature can be a protrusion withwhich the first mating feature mates. Hence, the terms “protrusion(s)”and “indentation(s)” are to mean “indentation(s) or protrusion(s)” areto be interpreted as such. Further, the terms “protrusion(s)” and“indentation(s)” are used in this description for illustrativenon-limiting purposes only. The protrusions 115 are configured to flexas the screw 120 (a portion 117 of the screw is shown in FIGS. 1 a-c) iscoupled to the extender housing 110. In some embodiments, protrusions115 are configured to be spring-loaded or otherwise be any lockingfeature, wherein upon insertion of the screw, the protrusions 115 areconfigured to retract toward the interior wall of the extender housing110 and then protract toward the indented features 105 upon protrusions115 being aligned with the features 105. Upon coupling, the protrusions115 are configured to snap into indented features 105, thereby lockingthe screw to the screw extender housing 110 and creating a rigidstructure. The interior walls of the housing 110 can further configuredto include threading 131 disposed near the proximal end 104. Thethreading 131 is configured to allow securing of various tools to theextender housing 110 during surgical procedures. As can be furtherunderstood by one skilled in the art, the terms “threading” or “thread”are used in this description of FIGS. 1 a-22 c for exemplarynon-limiting purposes and instead of threading components together,other means of compression and/or distraction and/or other ways ofcoupling can be used.

In some embodiments, the screw 120 can be a poly-axial screw that allowsa surgeon to manipulate (rotate, tilt, etc.) the combination of thescrew 120 coupled to the housing 110 once the screw is implanted into abony matter (e.g., vertebrae) of the patient. The screw 120 furtherincludes threading 124 on a threaded shaft of the screw that isconfigured to assist in insertion of the screw into a bony matter. Thethreaded shaft is coupled to the head of the screw 122. The head of thescrew 122 includes a passageway 126 that is configured to be wide enoughto accommodate placement and securing of a rod. The passageway 126 isconfigured to be aligned with the channel 112 so as to create acontinuous channel between the screw and the screw extender. In someembodiments, the passageway 126 can be configured to include threading138 disposed on passageway's interior surfaces. The threading 138 allowsplacement of set screws (not shown in FIGS. 1 a-c) to secure a rod onceit is installed into the screw.

FIGS. 2 a-b illustrate another exemplary screw extender system 200,according to some embodiments of the present invention. FIG. 2 aillustrates the screw extender housing being coupled to the screw andFIG. 2 b illustrates the screw extender housing being uncoupled from thescrew. As shown in FIGS. 2 a-b, a screw 220 is configured to be coupledto a screw extender housing 210. The screw extender housing 210 isconfigured to be an elongated tube that includes openings at both of itsends 202 (proximal), 204 (distal) for coupling to the screw 220 at oneend 204 and for insertion of surgical instruments at the other end 202.The housing 210 further includes slots or channels 212 that extend alongat least a portion of the housing 210 and are further configured toaccommodate placements of rod(s). Additionally, the housing 210 furtherincludes indentor portions or screw-locking features 240, which areconfigured to secure the screw 220 to the screw extender device housing210. In some embodiments, the housing 210 includes two indentor portions240 (second portion is not shown in FIG. 2 a). The indentor portions 240are configured to be fixed to the housing 210 at a location 237, whichis disposed toward the screw-coupling end 204. In some embodiments, theindentor portions 240 are configured to be welded at a location 237.Once the screw 220 is loaded into the extender device (See, FIG. 2 a),the indentor portions 240 are configured to engage the screw 220 usingprotrusions 242 that are disposed on an interior wall of the indenterportions 240 and are further configured to protrude into the interior ofthe housing 210. In some embodiments, the indenter portions 240 areconfigured to be flexible.

The indenter portions 240 are configured to engage an opening 251 in thehead of the screw 220, as shown in FIG. 2 b. Upon insertion of the screw220 into the extender device housing 210, the indenter portions 240 areconfigured to spread apart from the center of the housing 210. In someembodiments, the indentor portions 240 are configured to be spring-likedevices that pull apart upon application of external mechanicalpressure. Once the screw 220 is inserted into the housing 210, theindenter portions 240 are configured to snap into openings 251 of thescrew 220. Upon snapping into openings 251, the indenter portions 240rigidly secure the screw 220 to the housing 210.

Similarly to the screw extender shown in FIGS. 1 a-c, the screw extenderhousing 210 includes an interior passageway 219 that is configured to beexposed by the channel 212 (either fully or partially stretching alongthe length of the housing 210). The channel 212 is configured to bealigned with a passageway 226 disposed on the head of the screw 222 soas to create a continuous channel between the between the channel 212and the passageway 226 for passing of tools, instruments, rods, etc.

FIGS. 3 a-c illustrate another exemplary screw extender housing 310,according to some embodiments of the present invention. The extenderhousing 310 includes two channels 312 and 332 that are configured toexpose the interior 319 of the screw extender housing 310. The channel312 is configured to be partially open (i.e., partially stretch outbetween proximal and distal ends) and channel 332 is configured to befully open (i.e., connect the proximal and distal ends), as illustratedin FIGS. 3 h and 3 c, wherein FIG. 3 c is a top cross-sectional view ofthe extender housing 310. The housing 310 further includes a grippingfeature (or features) 391 that is configured to be disposed along edgesof the channel 312 and/or channel 332, as shown in FIGS. 3 a-b. Thegripping feature 391 is configured to assist in providing additionalsupport to the distractor/compressor device shown in FIGS. 14 a-e anddiscussed below, in some embodiments, the gripping feature 391 isconfigured to form a small cavity disposed along edges of the channels.In some embodiments, the gripping features 391 can have a shape of asemi-circular cavity. The gripping features 391 can be configured to bedisposed along the entire length of the channels 312 and/or 332 or alonga portion of the channels.

Similarly to the screw extenders shown in FIGS. 1 a-2 b, the screwextender housing 300 can include interior threads 331 disposed adjacentthe proximal end 302 of the screw extender housing 300. The screwextender housing 310 further includes a locking feature 340 disposedtoward the distal end 304 for interlocking with a screw in a similarfashion as the screw extender shown in FIGS. 2 a-b.

FIG. 3 d is a cross-sectional view of a portion of the distal end 304 ofthe screw extender housing 310. FIG. 3 d further illustrates in thelocking feature 340 having a protrusion 371 that is configured to matewith an opening disposed on a head of the screw (not shown in FIG. 3 d),similar to the feature 240 shown in FIGS. 2 a-c. The locking feature 340further includes a stopping mechanism 379 that is configured to preventa screw extender removal tool (shown in FIGS. 8 a-8 d and discussedbelow) from over rotating once it is placed inside the screw extenderhousing's interior for the purposes of removing the screw extenderhousing from the screw. In some embodiments, the stopping mechanism 379is configured to prevent rotation of the screw extender removal tool bymore than 90 degrees. As can be understood by one skilled in the art,the stopping mechanism can prevent any angle of rotation.

As can be understood by one skilled in the art, the channels formed bythe screw extender housing channels and the screw do not need to becontinuous. For example, a channel on the extender housing can havemultiple discontinuities disposed throughout the housing. As can be alsounderstood by one skilled in the art, the screw extender housing can beconfigured to include one or more first mating features (or indentors,or indented features, or indentor portions, etc.) upon release of one ofthem, the extender housing can be configured to disengage from thescrew.

FIG. 4 a-b illustrate an exemplary screw 400 configured to be used withscrew extenders shown in FIGS. 1 a-3 d and discussed above, according tosome embodiments of the present invention. The screw 400 includes adistal end 404, a proximal end 402, a shaft 421 having threads 424disposed along its length, and a head of the screw 408 coupled to theshaft 421. The head of the screw includes a passageway 426 that is sizedand configured to accommodate placement and securing of a rod. To securethe rod inside the screw head 408, the rod is placed into an interiorspace 425 created by the passageway 426 and then a set screw (not shown)is placed on top of the rod and secured using threads 415 disposed onthe interior walls of the passageway 426. The passageway 426 can beconfigured to include recessed edges 420 (a, b, c, d) that areconfigured to accommodate placement of the screw extender housing (shownin FIG. 5). The head of the screw further includes openings 410 that areconfigured to receive protrusions of the locking features disposed onthe screw extender housing (as shown in FIGS. 2 a-3 b).

Referring to FIG. 5, to further secure the screw 500 (similar to thescrew 400) to the extender device housing 512, the housing 512 includesa plurality of protrusions 510 (a, b, c, d). The protrusions 510 areconfigured to engage recessed edges 509(a, b, c, d), respectively, ofthe head 528 of the screw 514. In some embodiments, the protrusions 510are configured to wrap around the recessed edges 509. Such interactionof screw's recessed edges 509 and extender's protrusions 510 furthersecures the screw 314 to the extender housing 512 and preventsdisplacement of the screw 514 from the housing 512. This configurationalso allows the surgeon (or any other medical professional) tocontrollably apply various forces to the screw (e.g., during placementof an implant, etc.), such translational, axial, torsional, or any otherforces. As can be understood by one skilled in the art, the screw 514and the housing 512 can have any number of recessed edges 509 andcorresponding protrusions 510. Additionally, the screw 514 can have anynumber of openings (not shown in FIG. 5, but shown in FIGS. 4 a-b) andthe housing 512 can have any number of corresponding indentor portions540 that interact with the openings.

As stated above, the screw extender aids in the placement of forexample, pedicle screws during spinal fusion procedures. In someembodiments, the surgeon (or other medical professional) attaches thescrew extender to the pedicle screw and maintains control of the screwfrom an exterior (for example, from outside of the skin incision). Thescrew extender provides strong attachment so that axial, lateral, andtorsional forces can be applied to the screw extender. The surgeontypically applies these forces to screw extenders to manipulate thevertebra to which pedicle screws are attached.

In some embodiments, the screw extender has a center-less tubular body.The extender includes various securing features, for example, flexibleindenters, for holding the screw in an axial plane along the axis of thescrew and the extender, where the securing features engage the recessededges of the screw. In some embodiments, the screw extender indentersare flexible and are fixed to the main body of the screw extender atonly one location (as shown in FIG. 3 a). This allows the screw extenderindenters to flex out of the way and allow the screw to be released fromthe screw extender. As stated above, extender's tubular body is alsopartially slotted to allow a rod to be placed in the typical fashion.

In other embodiments, the system includes a screw extender remover toolshown in FIGS. 8 a-d, FIGS. 8 a-b illustrate one embodiment of a screwextender remover tool 800 and FIGS. 8 c-d illustrate another embodimentof a screw extender remover tool 850.

Referring to FIGS. 8 a-b, the remover tool 800 includes a shaft 833disposed between a distal end 864 and a handle 862. In some embodiments,the handle 862 is configured to have a rounded shape. As can beunderstood by one skilled in the art, the handle can be configured tohave any desired shape. The shaft 833 further includes a threadedportion 823 disposed substantially adjacent to the handle 862 and astopping mechanism 821 disposed between the handle and the threadedportion 823. The shaft 833 is configured to fit into the interiorpassageway 819 of the extender housing 810, as shown in FIG. 8 a. Thethreaded portion 823 is configured to interact with an interior threadedportion 825 of the screw extender housing 810 upon insertion of removertool 800 into the screw extender housing 810, as shown in FIG. 8 b. Uponinsertion of the remover tool 800, the threaded portions 823 and 825 areconfigured to interact with each other and a surgeon (or any othermedical professional) begins to rotate the remover tool in a downwarddirection (e.g., clockwise direction) in order to advance the removertool toward the screw. The remover tool is advanced until the stoppingmechanism 821 prevents its further advancement toward the screw. In someembodiments, the length of the remover tool's shaft can be appropriatelyselected so that upon full insertion of the remover tool, its distal end864 is configured to interact with flexible plates 817 containingprotrusions 815 and to push the plates 817 apart, thereby causingdisengagement of the screw extender housing 810 from the screw. Thestopping mechanism 821 is further configured to prevent over-insertionof the remover tool and thus, damage to the screw.

Thus, to remove or disengage the extender housing 810 from the screw, athreaded shaft 833 is inserted down the long axis of the extenderhousing. This threaded shaft 833 engages the threads 825 of the extenderhousing and forces the distal indented ends of the extender apart. Thismechanism releases the bone screw by releasing the tabs or flexibleplates 817 in the screw extender from its mating hole in the screw.

FIGS. 8 c-d illustrate an alternate embodiment of the remover tool 850,according to some embodiments of the present invention. The remover tool850 includes a shaft 853, a stopping mechanism 857, and a handle 851. Insome embodiments, the handle 851 can be configured to be cannulated onthe inside to allow passage of additional devices through it, as shownin FIGS. 18 a-c. Such additional devices can be configured to be used toassist in removal of the screw extender from the screw in the event thatthe remover tool 850 is unable to disengage from the screw.

As shown in FIGS. 8 c-d, the remover tool 850 is configured to fitinside the extender housing 820 and to be advanced toward the distal endof the housing upon application of a downward force by the surgeon (orany other medical professional). The stopping mechanism 857 isconfigured to prevent over-insertion of the remover tool 850 and thus,damage to the screw. The remover tool 850 further includes at least oneprotrusion 861 extending from an outer surface of the shaft 853 of theremover tool 850 substantially adjacent the distal end of the shaft 853of the remover tool. The protrusions 861 are configured to interact withthe flexible portions 840 of the extender housing 810 when the removertool 850 is fully inserted into the screw extender housing (i.e., thestopping mechanism 857 is configured to interact with a proximal end ofthe screw extender housing) and rotated by the surgeon. Upon interactionof the protrusions and flexible locking features, the protrusions 861are configured to push on the flexible locking features 840, thuspushing them away for the interior passageway of the screw extender andthereby unlocking the screw extender housing from the screw. In someembodiments, a stopping mechanism 379 shown in FIG. 3 d preventsover-rotation of the remover tool once it is inserted into the housingof the screw extender. The stopping mechanism 379 can be a protrusiondisposed on an inner surface of the extender housing substantiallyadjacent to the flexible indenters. The stopping mechanism 379 can befurther disposed in the path of the rotating protrusions 861, thus,preventing rotation of the remover tool beyond a particular point. Insome embodiments, the stopping mechanism 379 is configured to preventrotation of the remover tool by more than 90 degrees. The stoppingmechanism is configured to assist the surgeon in determining when theflexible members have been pushed apart and thus it is safe to removethe extender housing.

FIG. 6 illustrates a closer view of the interaction of the distal end ofthe remover tool 679 (which is similar to the remover tool 850) with theextender housing 610. As shown, the distal end of the remover tool 679includes protrusions 675 that are configured to extend away from thesurface of the remover tool 679. The flexible portions 640 (a, b)(similar to those shown in FIGS. 2 a-3 c) include protrusions 642 (a,b), respectively, that are configured to be removed from the openings inthe screw upon rotation of the remover tool and subsequent interactionof the protrusions 675 of the remover tool with the flexible portions640.

Thus, for the surgeon to remove the screw extender 610 from the screw(which is typically done after completion of a procedure), the screwextender remover device 679 is used. In addition to the components shownin FIGS. 8 c-d, the remover device 679 includes a tip having protrusionsor ramps 675. The ramps 675 are configured to be disposed around theperimeter of the tip. The shaft and the tip of the remover device can becylindrical in order to match the cylindrical housing 610 of theextender device 600. As can be understood by one skilled in the art, theshaft and the tip have any other shape and can correspond to the shapeof the housing 610.

In some embodiments, the tip can be smaller than the shaft (e.g., thediameter of the tip is smaller the diameter of the shaft). The shaft isalso sized to tit inside the housing 610 of the extender device 600. Thestopping mechanism or a stopper rim 823 (see, FIGS. 8 c-d) that acts asa stopper and limits the depth at which the remover device 679 can beplaced into the housing 610, thereby controlling the depth that theramps 675 can engage the screw extender's indentor portions 640 (shownin FIG. 6).

The ramps 675 are configured to protrude away from the surface of thetip. The ramps 675 interact with the indentor portions 640 of thehousing 610, as illustrated in FIGS. 6-7 b, wherein FIGS. 7 a-billustrate a bottom view of the remover tool interacting with theindentor portions. To remove the extender device 600 from the screw, theremover device 679 is inserted into the hollow housing 610 via itsproximal end (not shown in FIGS. 6-7 b). In some embodiments, the ramps675 of the remover device 679 cart be aligned with the channels 619during insertion of the remover device 679 into the housing 610. Assuch, during insertion, the ramps 675 slide down the channels 619 (asshown in FIG. 6). The insertion of the device 679 continues until thestopper rim of the remover device (not shown in FIG. 6) comes in contactwith the proximal end of the extender housing. At this point, the device679 is rotated about 90 degrees (in any direction) by gripping thehandle of the remover device (shown in FIG. 8 c-d) and twisting it in anappropriate direction. By rotating the handle, the ramps 675 come incontact with the indentor portions 640. Due to flexible nature of theindentor portions 640, the ramps 675 are configured to push the indentorportions 640 towards exterior portion of the housing 610 of the extenderdevice 600. As the portions 640 are pushed apart, the indentorprotrusions 642 disengage from the openings of the screw. Once theprotrusions 642 are removed from the openings in the head of the screw,the extender device 600 becomes loose and can be removed from the screw.In some embodiments, the extender device 600 and the remover device 610can be removed at the same time. As can be understood by one skilled inthe art, other ways of removing the screw extender housing from thescrew are possible.

FIGS. 18 a-c illustrate an exemplary supplemental screw extender removerdevice 1810, according to some embodiments of the present invention. Inthe event that a surgeon is unable to disengage the screw extenderdevice from the screw, the device 1810 can assist the surgeon in pushingthe screw extender away from the screw. As shown in FIGS. 18 a-c, thesupplemental remover device 1810 includes a shaft 1803 disposed betweenthe distal tip 1807 and a handle 1801. The supplemental remover device1810 is configured to have a smaller diameter than that of the removertool 850. The shaft 1803 of the device 1810 is configured to be longerthan that of the remover tool 850. The remover tool 850 includes aninterior cannulated portion (not shown in FIGS. 18 a-c) that is disposedwithin the remover tool 850 and that further accommodates insertion ofthe device 1810, as shown in FIGS. 18 a-b. The device 1810 furtherincludes a threaded portion 1805 configured to be disposed substantiallyadjacent the handle 1801. The threaded portion 1805 is configured tointeract with a threaded portion disposed inside the handle 851 of thedevice 850.

Thus, in the event that the surgeon cannot remove the screw extenderdevice 1802 from the screw 1807 using just the remover tool 850, thesurgeon inserts the device 1810 through an opening in the handle 851 ofthe remover device 850 and pushes the device 1810 along the interiorchannel (i.e., cannulated portion) of the remover device 850, untilthreaded portion 1805 comes in contact with an interior threaded portionof the remover device 850. At this time, the surgeon begins to rotatethe device 1810 along the threaded portion, thereby protruding the tip1807 of the device 1810 beyond the distal tip of the remover device 850.Thus, the tip 1807 comes in contact with the screw 1804 and effectivelypushes the screw extender 1802 along with remover tool 1810 away fromthe screw, thus, allowing the surgeon to remove the screw extender.

In some embodiments, the screw extender system of the present inventioncan be utilized for delivery of a percutaneous wire, which can then beutilized for advancement of a rod. Initially, to perform a spinalsurgery using the screw extender device of the present invention, thesurgeon initially makes an incision at a location where a first screwalong with a first screw extender device is to be implanted. Anotherincision can be made at another location where a second screw along witha second screw extender are to be implanted. As can be understood by oneskilled in the art, the surgeon can make as many incisions as arenecessary for creating a spinal stabilization system according to thepresent invention. Once, the incisions are made, the surgeon can couplethe screw extenders with the screws and advance this combination towardthe bony matter (e.g., vertebrae) for subsequent insertion. Once thescrew-extender-and-screw combination are inserted, the surgeon is ableto manipulate to the screw extenders and the screws for insertion ofpercutaneous wires and/or rods and/or other tools and device. In someembodiments, the screws can be poly-axial screws that allow the surgeonto manipulate the screw extenders in any direction while the screwextenders are rigidly attached to the screws.

FIGS. 9 a-9 h illustrate exemplary percutaneous wire insertion devices900 and 950, according to some embodiments of the present invention. Thedevices 900 and 950 are configured to be inserted into the screwextender's hollow interiors for guiding a percutaneous wire along andbetween the screw extenders. Referring to FIGS. 9 a-c and 9 h, a firstpercutaneous wire insertion device 900 is illustrated. The device 900includes a shaft 920 disposed between a proximal end 902 and a distalend 904. The device 900 is configured to be cannulated and thus includesan interior channel 941 configured to be disposed between an opening atthe proximal end 902 and an opening 930 disposed at the distal end 904of the device 900. In some embodiments, the opening 930 is configured tobe placed on the side of the device 900 so as to accommodate advancementof the wire toward another screw extender.

In some embodiments, the device 900 further includes two pans 927 a and927 b that are configured to be coupled using a nut or any other lockingmechanism 922 that is configured to be placed adjacent the proximal end902 of the device 900. The two-part configuration is provided for easeof removal of the device 900 from the screw extender. The two parts 927are configured to be coupled using hook features 932 and 933 disposed atthe distal end 902 of the device and the nut 922 disposed adjacent theproximal end 904 of the device 900. The nut 922 further includesthreading 924 that is configured to interact with the threading disposedat a proximal end of the screw extender on the screw extender's innersurface.

To secure the device 900 inside a screw extender device, the surgeoninserts the assembled device 900 with the distal end 904 into the screwextender's proximal end and slides the device 900 along the interiorpassageway of the screw extender until the threads 924 of the device 900begin to interact with the screw extender's interior threads disposed atthe proximal end of the screw extender. At this point, the surgeonbegins rotation of the nut 922, thereby screwing the nut 922 into thescrew extender without rotation of the shaft 920 of the device 900. Uponinsertion of the device 900 into the screw extender, the distal end 904of the device 900 is configured to fit within the passageway of the headof the screw. This allows proper alignment of the opening 932 towardanother screw extender. In some embodiments, upon placement of thescrews and respective screw extenders, the surgeon can manipulate thescrew extenders (coupled to the screws) so that the channels disposed onthe extenders' exterior surfaces are aligned toward each other. Thedevice 900 can be inserted with the opening 930 pointed toward thesecond screw extender that has been already installed into patient'svertebrae. During insertion of the wire through the device 900, the wireis advanced along the interior channel 941, out of the opening 930 andtoward the second extender through patient's muscle tissue.

As stated above, the device 900 is configured to be separated into toportions 927 a and 927 b. In some embodiments, the portion 927 a isconfigured to include the channel 941 for advancing the wire along thedevice 900. The channel 941 is configured to begin at the proximal endof the device 900 and protract through the entire length of the portion927 a toward the opening 930 disposed on the side of the device 900. Insome embodiments, the channel 941 is configured to be curved toaccommodate bending of the wire during advancement.

In some embodiments, the device 900 can include a balancing feature 925configured to extend away from the surface of the shaft 920. The feature925 is configured to prevent the device 900 from wobbling once it isinserted into the interior passageway of the screw extender.

The second device 950, shown in FIGS. 9 d-g, is configured to include ashaft 951 disposed between a distal end 914 and a proximal end 912. Insome embodiments, the shaft can be configured to have a unitarystructure as opposed to a two-part structure of the device 900. Thedevice 950 further includes a nut or any other locking mechanism 947disposed substantially adjacent the proximal end of the device 950. Thenut 947 further includes threading 948 configured to interact with thethreading disposed at a proximal end of the screw extender on itsinterior wall. The nut is configured to be coupled to the shaft 951 atthe proximal end 912. The device 950 further includes a wire-pinching ora wire-holding mechanism 957 disposed at the distal end 914 of thedevice 950 and that is configured to pinch or secure the wire once thewire is advanced from the first screw extender (containing device 900)through patient's muscle tissue. The wire-pinching mechanism 957includes an opening 959. Upon advancement of the wire from the firstscrew extender and through the muscle tissue, the opening 959 isconfigured to receive the wire, which is then secured by thewire-pinching mechanism 957. The wire-pinching mechanism 957 iscontrolled by a knob or any other locking feature 945 disposed at theproximal end 912 of the device 950. The knob 945 is configured to becoupled to a shaft 955 that is inserted through the interior of theshaft 951 of the device 950. The shaft 955 is configured to have asmaller diameter than the diameter of the shaft 951. The shaft 955further includes a threading 913 that is configured to mate with athreading disposed on an interior surface of shaft 951 (not shown). Uponsuch mating, the surgeon can begin rotating the knob 945, therebyadvancing the shaft 955 through the opening 959, as illustrated in FIGS.9 f-g. Upon advancement of the shaft 955, the shaft 955 is configured todecrease available space within opening 959, thereby pinning the wire toone of the walls of the opening 959.

FIG. 12 illustrates an exemplary wire 1010, according to someembodiments of the present invention. The wire 1010 includes a distaltip 1210 that is configured to lead the wire through the first extender(and the device 900), through the patient's muscle tissue, and into thesecond extender (and the device 950). The wire 1010 also includes aproximal end 1212 to which a rod 1984 is attached. The rod 1984 containsa hole where the wire interlocks with the rod. This attachment can havea thread or a mechanical attachment mechanism. The rod also contains afeature on the far proximal portion of the rod, (the end not attached tothe wire). This prevents the rod from being pulled through the screwextender. As can be understood by one skilled in the art, any other waysof coupling the wire to the rod are possible, e.g., any mechanicalcoupling of the wire and the rod are possible. In some embodiments, suchcoupling can be configured to allow for a quick release of the rod fromthe wire.

In some embodiments, the wire 1010 can be configured to be advancedusing a wire-advancement device or a wire advancement gun 1100, as shownin FIGS. 11 a-b. FIG. 11 a illustrates a cross-sectional view of the gun1100 and FIG. 11 b illustrates a perspective view of the gun 1100. Insome embodiments, the gun 1100 includes a fixed handle 1102, anactuating handle 1104, and a barrel 1106 coupled to the handles 1102 and1104. The barrel 1106 is configured to include a loading opening 1114disposed at a proximal end of the barrel 1106 and a discharge opening1112 disposed at a distal end of the barrel 1106. The wire 1010 (notshown) is configured to be loaded into the loading opening 1114 anddischarged through the discharge opening 1112 by advancing the wirethrough the barrel 1106. The actuating handle 1104 is configured to bespring-resistance-loaded with respect to the fixed handle 1102, i.e.,upon squeezing the actuating handle 1104 toward the fixed handle 1102, aratcheting mechanism 1110 is configured to cause advancement of the wire1010 through the barrel 1106 and then forcing the handle 1104 to springback to its original position. In some embodiments, the surgeon, uponsqueezing the handle 1104 multiple times, can advance the wire 1010 toany desired length. As can be understood by one skilled in the art,other methods and/or instruments of advancing the wire 1010 are possibleand are not limited to the wire advancement device 1100 shown in FIGS.11 a-b.

FIGS. 10 a-e illustrate an exemplary procedure for advancement of wire1010 through screw extenders 1002 and 1004. As stated above, prior toadvancement of wire 1010, a surgeon (or any other medical professional)makes an incision above the location of implantation of a spinalstabilization system (represented by a screws, wires, rods, or any otherdevices), where the incision is configured to correspond to the locationwhere a first combination of a screw and a screw extender (i.e., screw1006, screw extender 1002) are to be implanted into patient's vertebrae.The surgeon can make another incision corresponding to the locationwhere a second combination of a screw and a screw extender (i.e., screw1008, screw extender 1004) are to be implanted into patient's vertebrae.Then, the surgeon implants first and second combination. The screwextenders are subsequently aligned so that the channels disposed ontheir housings (i.e., channels 1012 disposed on the first screw extender1002 and channels 1014 disposed on the second screw extender 1004;wherein channels can be partially open or fully open, as discussedabove) are facing each other. Along with the channels, the passagewaysin the heads of the screws (i.e., passageway 1016 in the head of thescrew 1006 and passageway 1018 in the head of the screw 1008) are alsoaligned, thus creating a virtual corridor between the passageways andthe channels.

Subsequent to the alignment procedure, devices 900 and 950 are insertedinto the interior portions of the housings of screw extenders 1002 and1004, respectively. The devices 900 and 950 are then secured usingappropriate knobs and threaded portions, as discussed in connection withFIGS. 9 a-h. During insertion, the surgeon also aligns devices 900 and950 so that the opening 930 on the device 900 is aligned with theopening 959 of the device 950 (not shown in FIG. 10 a). The wireadvancement device 1100 is loaded with the wire 1010 and is then coupledto the device 900, as shown in FIG. 10 a. Upon coupling of the device1100, the opening 1112 in the barrel of the device 1100 is aligned withthe opening on the device 900 disposed at a proximal end of the device900 so that the wire 1010 can safely pass through the interior channel941 of the device 900 (not shown in FIG. 10 a).

As the surgeon advances the wire 1010 using the device 1100, the wire1010 begins to travel along the channel 941 of the device 900 and isconfigured to advance out of the opening 930 of the device 900. Then,the wire 1010 begins to travel through the muscle tissue toward thesecond screw extender 1004. In some embodiments, the wire 1010 can beconfigured to have a sharpened tip in order to pierce through the muscletissue. As the wire 1010 is advanced further, it reaches and is passedthrough the opening 959 of the device 950 disposed within the secondscrew extender 1004. As the sufficient length of wire has passed throughthe opening 959, the surgeon actuates the pinching mechanism of thedevice 950, which compresses the wire 1010 in the device 950. Thesurgeon can observe wire advancement using X-ray.

Once the wire 1010 is secured in the device 950, the surgeon removes thewire-advancement device 1100, as illustrated in FIG. 10 b. In someembodiments, the device 1100 can be simply slid off the wire 1010. Thus,at this stage, the wire remains secured by the device 950 and bothdevices 900 and 950 are secured within their respective screw extenders1002 and 1004. Then, the surgeon removes the nut 922 by unthreading italong the threads 924 (as shown in FIGS. 9 a-b) and removes the portion927 b followed by removal portion 927 a of the device 900 from the screwextender 1002, as shown in FIG. 10 c. The device 950 still remains inthe second screw extender 1004. Referring to FIGS. 10 d-e, the surgeonremoves the device 950 by unscrewing it from the housing of the extender1004. The device 950 is removed while the wire is being held by thepinching mechanism 957. Upon removal of the device 950, the wire 1010 isconfigured to protract through the first extender 1002, through themuscle tissue of the patient disposed between extenders 1002 and 1004,and the second extender 1004 while being coupled to the removed device950.

In some embodiments, the rod 1984 (shown in FIG. 104) can be configuredto be advanced along with the wire 1010 (or follow the wire through thescrew extender 1002 and then along the virtual corridor in the muscletissue created by the wire) for installation between two screws. FIGS.10 f-g illustrate advancement of the rod 1984 along the wire 1010, whereFIG. 10 f is a perspective view of the installed rod and FIG. 10 g is across-sectional view. The rod 1984 can be configured to include anadvancing tip 1952 disposed at a distal end of the rod 1050 and aproximal end 1954 of the rod 1984 that in some embodiments can beconfigured to be coupled to a rod inserter (discussed below in detail).The rod's advancing tip 1952 is configured to travel from the firstscrew extender 1002 along the passageway created by the wire 1010 in themuscle tissue of the patient to reach the second screw extender 1004.Once the rod 1984 is disposed in the passageways of screws 1006 and 1008that are coupled to the respective screw extenders 1002 and 1004, therod 1984 can be secured using setscrews 1072 that can be advancedthrough the interior of the screw extenders using a setscrew settingdevice 1070, as shown in FIG. 10 h. The setscrew setting device 1070 canbe configured to carry a setscrew at its distal tip and then uponinsertion into the passageway in the head of the implanted screw beginrotating the setscrew (having appropriate threads) along the threadsdisposed on the interior of the passageway of the implanted screw. Uponsetting the setscrew, the device 1070 can be released from the setscrew1072 and removed from the interior of the screw extender. Upon removalof the setscrew setting device 1070, the screw extenders can be removedusing the remover tools discussed above.

During installation of the spinal stabilization system of the presentinvention, the surgeon may wish to compress or distract the screwextenders that are coupled to the screws, which are implanted intopatient's bony matter. FIGS. 13 a-13 f and 14 a-e illustrate variousembodiments of compressor/distractor tools. In some embodiments, thecompression motion can be characterized by pushing the distal ends ofthe screw extenders closer to each other and by pulling the proximalends of the screw extenders away from each other. The distraction motioncan be characterized by pushing the proximal ends of the screw extenderscloser to each other and by pulling the distal ends of the screwextenders away from each other (i.e., a reverse of the compressionmotion).

FIGS. 13 a-f illustrate an exemplary compression/distractor tool 1300,according to some embodiments of the present invention. The tool 1300includes a housing 1310, compression/distraction arms 1304 (a, b),ratchet handle 1302, fulcrum 1312, and a release handle 1320. The arms1304 are configured to be coupled to the housing 1310 using respectiveshoulders 1315 (a, b). The arms 1304 are configured to substantiallyperpendicularly protrude away from the housing 1310 in the samedirection. The ratchet handle 1302 is configured to be disposed on theside of the housing 1310 that is opposite to the side where the arms1304 are disposed. The ratchet handle 1302 is configured to causemovement of the arms 1304 to and from each other. The ratchet handle1302 can be configured to use any conventional ratcheting mechanism foractivating such translational movement of the arms 1304. In someembodiments, the ratchet handle 1302 can be configured to have agripping portion to allow for better gripping of the handle 1302. Thearms 1304 further include respective inner cavities 1308 (a, b) that areconfigured to accommodate placement of the screw extenders between thearms 1304 and the fulcrum 1312. The fulcrum 1312 can be configured tohave a rhombus shape (as can be understood by one skilled in the art,other shapes are possible) that creates pivot points for the screwextenders being secured between the arms 1304 and the fulcrum 1312. Thepivot points are configured to allow tilting of the of the screwextenders either during compression or distraction motions. In someembodiments, the fulcrum 1312 can be configured to be rotated to allowfor variable angle distraction/compression of extenders. In someembodiments, the arms 1304 can be configured to include respectiveopenings 1306 (a, b) configured to accommodate insertion of pins 1353(a,b), which serve for attachment of an anti-torque device 1370 (shown inFIG. 13 f).

In order to prevent slippage of the screw extenders, an anti-splaydevice 1351 (shown in FIG. 15) can be placed over each of the proximalends of the extender housings prior to performing anydistraction/compression. In some embodiments, the anti-splay device canalso be anti-torque device. As can be understood by one skilled in theart, the terms “anti-splay” and “anti-torque” are used interchangeablyin this description and an anti-splaying device can be configured tohave anti-torque capabilities and vise versa. The anti-splay device 1351includes a body portion 1504 coupled to an anti-splay portion 1357. Thebody portion 1504 is configured to be coupled to the housing of thescrew extender using any known methods (e.g., hook-and-slide (shown inFIG. 15), snap-fit, or any other ways). The anti-splay portion 1357 isconfigured to interact with the arms of the 1304 or any other parts(e.g., fulcrum 1312) of the device 1300, as shown in FIGS. 13 e-f. Uponcoupling, the anti-splay device 1351 and the screw extender housingcreate a unitary structure that can withstand the forces being appliedto it during compression/distraction motions. The anti-splay portions1357 can be configured to have mesh-like surface that is configured tocreate friction between components of the device 1300 and the anti-splaydevices 1351.

Referring to FIG. 13 e, the screw extenders 1341 (a, b) are configuredto be arranged in the device 1300 for the purposes of compression, i.e.,pulling of the proximal ends of the screw extenders apart from eachother. For compressing the screw extenders, the anti-splay devices 1351(a, b) are coupled to proximal ends of the respective screw extenders1341(a, b). The device 1300 is configured to be arranged so that thefulcrum 1312 is disposed above the arms 1304 (a, b) in relation to theproximal ends of the screw extenders. The screw extenders 1341 areconfigured to be arranged between the respective arms 1304 and thefulcrum 1312, as shown in FIG. 13 e. Once the screw extenders 1341 alongwith anti-splay device 1351 are secured between the respective arms 1304and the fulcrum 1312, the handle 1302 is further rotated to tilt thescrew extenders 1341 about side edges of the fulcrum 1312, therebycausing the distal ends of the extenders 1341 to be pushed together,whereas the proximal ends of the extenders 1341 are pulled apart. Insome embodiments, an anti-torque device 1370 can be coupled to the pins1353 to prevent slippage or any other movement of the extenders whileperforming compression. To increase the angle of inclination of theextenders 1341, the surgeon can continue rotating the handle 1302. Torelease the handle 1302 after compression, the handle 1320 is depressed.

FIG. 13 f illustrates a reverse motion of distraction. To perform thismotion, the device 1300 is turned upside down in relation to the motionof compression situation, whereby the fulcrum 1312 is arranged below thearms 1304, as shown FIG. 13 f. During distraction, the arms 1304 amconfigured to interact with the anti-splay portions 1357 of theanti-splay devices 1351. By rotating the handle 1302, the device 1300 isconfigured to push the proximal ends of the extenders closer togetherwhile pulling the distal ends of the extenders apart. The anti-torquedevice 1370 can also be attached to the pins 1353 to prevent slippage ofthe device.

In some embodiments, the arms 1304 can be “powered” by a rack and pinionor a mechanical link system. In some embodiments, the anti-splay device1351 further prevents the extenders from splaying, bending, orundergoing flex during activities such as distraction, compression,torsion, and axial loads common in manipulating vertebra during spinesurgery.

FIGS. 14 a-e illustrate another exemplary compressor/distracter device1480, according to some embodiments of the present invention. The device1480 includes a housing 1482 that includes an elongated opening betweentwo rails 1491 (a, b) running in parallel to each. The rails 1491 areconfigured to be connected at one end using an elevated rounded section1483 and at the other end using a connection rod 1493. The device 1480further includes a crank-and-ratchet mechanism 1474 that is configuredto slide along the rails 1491 using a sliding mechanism 1490 disposedwithin each rail. The rail 1491 a further includes a plurality ofratchet teeth 1484 with which a ratchet wheel 1495 of the mechanism 1474is configured to interact, as shown in FIG. 14 c. The mechanism 1474further includes a handle 1481 that is coupled to the ratchet wheel 1495and configured to cause rotation of the ratchet wheel 1495. Themechanism 1474 further includes a release handle 1482 that is configuredto allow movement of the mechanism toward the elevated portion 1483 andprevent a reverse motion of the mechanism 1474. Upon depressing of therelease handle 1482, the mechanism 1474 is released and is allowedmovement (i.e., translation) away from the elevated portion 1483.

The elevated portion 1483 of the device 1480 includes a spring-loadedlocking feature 1488 having two spring-loaded locking pins 1489 (a, b)connected by a rod 1499. The rod 1499 and the elevated portion 1483 areconfigured to create an opening 1485 for insertion of a screw extenderdevice, as shown in FIGS. 14 d-e. In some embodiments, the screwextender device housing's features 391 shown in FIGS. 3 a-b areconfigured to interact with the rod 1499 and prevent movement of thescrew extender device inside the opening 1485. A second screw extenderdevice can be inserted into an opening created between the rails 1491,the rod 1499 and the mechanism 1474. The second screw extender can besecured by translating mechanism 1474 along the rails 1491, until thesecond screw extender is secured between the rod 1499 and the mechanism1474. In some embodiments, each of the openings 1485 and 1487 areconfigured to be sized to allow insertion and securing of the screwextenders. The spring-loaded features 1489 are configured to be lockedin using a screwdriver or any other tool. Referring to FIG. 14 d, amotion of distraction is shown, whereby the distal ends of the screwextenders are pulled apart. During this motion, the device 1480 isconfigured to be secured so that the ratchet teeth 1484 are facingupwards. FIG. 14 e illustrates a motion of compression, whereby theproximal ends of the screw extenders are pulled apart. In this case, theratchet teeth 1484 are configured to face downwards. The device shown inFIGS. 14 a-c is advantageous as no anti-splay or anti-torque devices arerequired to maintain stability of the screw extenders duringdistraction/compression motions.

FIGS. 16 a-c illustrate an exemplary caliper tool 1600 having screwextender attachment barrels 1602 (a, b) that are coupled to a measuringruler 1604, whereby the measuring ruler 1604 is configured to beslidably coupled to the band 1602 a (for example) and fixed to thebarrel 1602 b. In some embodiments, the barrels 1602 are also coupled torespective handles 1603(a, b) that are configured to allow a surgeon toeasily translate the barrels 1602. The barrels 1602 are configured to behollow inside and are appropriately sized to accommodate placement ofthe screw extenders. The caliper tool 1600 assists the surgeon indetermining the length of a rod that is needed to for a particularsurgery.

Upon installation of the screw extenders into the vertebrae, the surgeonplaces the barrels 1602 over the proximal ends of the screw extenders(as shown in FIG. 16 c) and slides one of the barrels 1602 a along theruler 1604. The ruler 1604 is configured to have markings 1608indicating an appropriate size of the rod needed for surgery. In someembodiments, the ruler 1604 can be configured to have a stoppingmechanism 1607 that prevents slippage of the barrels 1602 from the ruler1604. Once the size of the implant is noted on the rule 1604, thecaliper tool 1600 can be removed from the extenders. In someembodiments, the moving barrel 1602 b can also include a locking feature1611 that the surgeon can use to lock the device upon determining theappropriate size of the rod.

FIGS. 17 a-c illustrate an exemplary screw extender guide tool 1700 forreinstalling the screw extender, according to some embodiments of thepresent invention. The tool 1700 can be used in the event that a screwextender is removed from (or for example, accidentally slips off) theinstalled screw and needs to be re-installed to the screw. The tool 1700can be used during any re-installation procedures.

The tool 1700 includes a hollow housing 1702 disposed between a distalend 1704 and a proximal end 1706. The proximal end 1706 is configured toinclude a handle 1708 that controls rotation of a threaded portion 1710disposed at a distal end 1704. The threaded portion 1710 is configuredto interact with the threaded portion inside the head of the screw (notshown in FIG. 17 a). Thus, in the event that the screw extender 1750 isremoved from the screw 1752 (either accidentally or not) and needs to bereinstalled, the tool 1700 is placed over the wire 1754 and sliddownwards along the wire 1754 and toward the screw 1752. Upon reachingthe screw 1752, the tool 1700 is screwed into the head of the screw 1752and thus, secured to the screw 1752. Once the tool 1700 is secured tothe screw, the extender 1750 can be advanced along the tool 1700 forcoupling to the screw in a similar fashion as described above. Aftercoupling of the extender 1750, the tool 1700 is unscrewed from the headof the screw 1752 and removed along the wire 1754. In some embodiments,the wire 1754 can be a guide-wire placed to outline a perimeter of thesurgical procedure and guide the surgeon during procedure.

FIGS. 19 a-e illustrate various embodiments of a rod inserter device,according to some embodiments of the present invention. FIGS. 19 a-billustrate an exemplary a rod inserter tool 1910. The rod inserter tool1910 includes a handle 1912 disposed at a proximal end of the tool 1910and a shaft 1914 coupled to the handle 1912. At a distal end of theshaft 1914, the shaft includes a rack-and-pinion mechanism 1920 that isconfigured to slide out of the shaft 1914 and to rotate a rod 1930 (thatwas previously coupled to the mechanism 1920) by approximately 90degrees. As can be understood by one skilled in the art, other angles ofrotation are possible. In some embodiments, such rotation isaccomplished through rotation of the handle 1912 that is coupled to rods1925 disposed within the shaft 1914. Rotation of the handle 1912 causesthe rods 1925 to push down the rods 1927 of the rack-and-pinionmechanism 1920, thereby causing the rotational motion of the rod 1930.Reverse rotation of the handle 1912 causes reverse rotation of the rod1930.

In some embodiments, the rod 1930 (which is similar to the rod 1984shown in FIG. 19 f) includes an opening 1979 disposed at its distal endand configured to be coupled to an insertion pin of the rack-and-pinionmechanism 1920. This allows the rod 1930 to be held in place by the rodinserter tool 1910, while the rod is being inserted into the screwextenders. The rod further includes ratchet teeth 1978 (shown in FIG.190 that are configured to be disposed at the distal end of the rod andfurther configured to interact with ratchet teeth 1922 of the mechanism1920. The ratcheting interaction of the rod 1930 and the mechanism 1920provides a controlled rotation of the rod 1930.

FIGS. 19 c-e illustrate another exemplary rod insertion tool 1950,according to some embodiments of the present invention. The tool 1950includes a shaft 1955 disposed between a distal end 1957 configured tobe coupled to a rod 1930 (in a similar fashion as with the tool 1910 inFIGS. 19 a-b) and a control handle 1959. The control handle 1959 isconfigured to be threadedly secured inside the shaft 1955 using threads1961. The control handle 1959 is further secured to an interior rod 1971that is disposed inside the shaft 1955 and is configured to slide insidethe shaft 1955. The rod 1930 is rotatably coupled to the interior rod1971. Upon rotation of the control handle 1959, the interior rod 1971begins to push on the pivoted connection between rod 1930 and interiorrod 1971, thereby causing the rod 1930 to rotate, as shown in FIGS. 19d-e. In some embodiments, the interior rod 1971 can be configured to bespring loaded inside the shaft 1955 using springs 1963, which cause thehandle 1959 to spring back upon completion of rotation of the rod 1930.In some embodiments, the rod 1930 can be configured to include a pivothole 1977 that is configured to disengage from the interior rod 1971upon rotation of the rod 1930. Thus, this allows for a release of therod 1930 from the interior rod 1971.

In some embodiments, the shaft 1955 further includes a measuring scale1967 disposed along a portion of the length of the shaft 1955. The scale1967 is configured to determine the proper depth of insertion of theinserter tool 1950 into the screw extender housing.

FIGS. 20 a-l illustrate a procedure for rod insertion using a tool 1910shown in FIGS. 19 a-b. Referring to FIGS. 20 a-d, the rod inserter tool1910 coupled to the rod 1930 (pointing towards the screw extender) isinserter into the first screw extender 2002. Upon insertion, the rod1930 is rotated to being protruding outside the exterior channels of thefirst screw extender 2002 and to begin pointing toward the second screwextender 2004, as shown in FIGS. 20 e-f. Then, the rod 1930 is advancedinto one of the exterior channels of the second screw extender 2004, asshown in FIGS. 20 g-j. Upon being inserted into the channels of thefirst and second screw extenders 2002 and 2004, the inserter tool 1910is disengaged, as shown in FIGS. 20 k-l. FIGS. 20 m-o illustrateinsertion of the rod 1930 using the tool 1950 shown in FIGS. 19 c-e.

FIGS. 21 a-e illustrate an exemplary rod reducer tool 2100 for reducingthe rod 1930 toward the implanted screw, according to some embodimentsof the present invention. The rod reducer 2100 includes a rod reducershaft 2102 coupled to a handle 2104. The handle 2104 is configured to berotatably coupled to the shaft 2102. The shaft 2102 is configured toinclude an interior passage 2120 for insertion over a screw extender.The reducer further includes handle threads 2132 and extender threads2135. The extender threads 2135 are configured to interact with thethreads disposed on an interior surface of the screw extender housing2165 (as shown in FIG. 21 a) and thus are configured to secure the tool2100 to the screw extender housing. The handle threads 2132 areconfigured to allow rotation of the handle 2104 once the reducer tool2100 is secured to the extender housing 2165. In some embodiments, thereducer tool 2100 includes a window 2140 disposed on the shaft 2102 thatallows a surgeon to get a visual confirmation that the extender housing2165 has been secured to the reducer tool 2100.

In some embodiments, the handle 2104 of the tool 2100 includes anopening 2108 that is configured to allow insertion of setscrews or othertools, once the reducer tool 2100 has aligned the rod 1930 and it istime to secure to the implanted screw.

FIGS. 22 a-b illustrate an exemplary rod inserter tool 2200, accordingto some embodiments of the present invention. The tool 2200 isconfigured to allow pushing of the rod 1930 disposed in the channelsbetween two extenders 2202 and 2204 toward the implanted screws. Thetool 220 can push the rod 1930 from a side of one of the extenders (asshown in FIG. 22 b) or between two extenders (as shown in FIG. 22 a).The scenarios shown in FIGS. 22 a-b may require different types ofincisions made. For example, the scenario shown in FIG. 22 a may requirea surgeon making an incision that connects the two incisions created forthe two extenders. In some embodiments, the tool 2200 includes anelongated shaft 2207 coupled to scissor-like handles 2209 at a proximalend and gripping jaws 2211 at a distal end. The gripping jaws 2211 areconfigured to grip the rod 1930 upon actuation of the handles 2209. Oncethe jaws 2211 have gripped the rod 1930, the surgeon can begin pushingthe rod toward the implanted screws.

In some embodiments, components of the present invention can bemanufactured from Nitinol or any other suitable materials.

In some embodiments, the above referenced extender devices can be usedby a surgeon (or any other medical professional) in a variety ofapplications. The extender devices can be used subsequent to preparationof a bone for screw-implantation. Screw is implanted using a bone biopsyneedle, such as a Jamshidi needle, manufactured by Cardinal Health Inc.,Dublin, Ohio, USA, which can be followed by progressive dilation. Oncethe bone has been prepared, the bone screw is implanted. Afterimplantation, the bone screw can be manipulated for orientation usingthe extender device. This “extender” extends out of the stab wound andallows the surgeon to control the implanted screw.

In a typical surgery, a plurality of bone screws can be implanted usingthe methods. In some cases, once an appropriate number of screws havebeen implanted into the bony matter of a patient, a rod and/or wire canbridge gaps between the screws. Placement and manipulation of screws canbe accomplished using the extender devices and various surgical tools,as shown in FIGS. 1 a-22 c. Following that, set screws can be tightenedand the guide wire can be removed. The extender device and use ofsurgical tools allows a surgeon (or other medical profession) to performa minimally invasive surgery of placing various fusion device, such asin the case of a spinal fusion procedures.

Although particular embodiments have been disclosed herein in detail,this has been done by way of example for purposes of illustration only,and is not intended to be limiting with respect to the scope of theappended claims, which follow. In particular, it is contemplated thatvarious substitutions, alterations, and modifications may be madewithout departing from the spirit and scope of the invention as definedby the claims. Other aspects, advantages, and modifications areconsidered to be within the scope of the following claims. The claimspresented are representative of the inventions disclosed herein. Other,unclaimed inventions are also contemplated. The applicant reserves theright to pursue such inventions in later claims.

1-50. (canceled)
 51. An instrument for compression and distraction of atleast two surgical screw implants, comprising: two rails running inparallel and configured to be connected at one end using an elevatedsection and at the other end using a connection rod, at least one railincluding a plurality of ratchet teeth; a housing, including a ratchetwheel, configured to slide between the two rails using a slidingmechanism disposed within each of the two rails; an actuator handlecoupled to the ratchet wheel and configured to rotate the ratchet wheelto engage the ratchet teeth and advance the housing; and a releasehandle configured to allow movement of the mechanism toward the elevatedsection and prevent a reverse motion of the housing.
 52. The instrumentof claim 51, wherein upon actuation of the release handle, the housingis released from and is allowed movement away from the elevated section.53. The instrument of claim 51, wherein upon actuation of the actuatorhandle, the housing advances toward the elevated section.
 54. Theinstrument of claim 51, further comprising a spring-loaded lockingfeature coupled with the elevated section that forms a first opening toreceive a first screw extender that attaches to a first spinal implant.55. The instrument of claim 54, wherein the spring-loaded lockingfeature comprises two spring-loaded locking pins connected by a lockingrod.
 56. The instrument of claim 51, wherein the rails, the housing, andthe locking rod form a second opening to receive a second screw extenderthat attaches to a second spinal implant.
 57. The instrument of claim51, wherein the locking rod creates a pivot point for compression anddistraction of the spinal implants by application of forces on attachedscrew extenders.
 58. The instrument of claim 57, wherein coupling theinstrument to the screw extenders in a first position with the lockingrod on a proximal side of the rails permits distraction of the spinalimplants.
 59. The instrument of claim 58, wherein coupling theinstrument to the screw extenders in a second position with the lockingrod between the rails and the surgical implants permits compression ofthe spinal implants.
 60. The instrument of claim 57, wherein couplingthe instrument to the screw extenders so that the ratchet teeth arefacing proximally causes the distal ends of the screw extenders to bepulled apart by actuation of the actuator handle.
 61. The instrument ofclaim 57, wherein coupling the instrument to the screw extenders so thatthe ratchet teeth are facing distally causes the proximal ends of thescrew extenders to be pulled apart by actuation of the actuator handle.